Bloomberg News

Mylan Wins Ruling Overturning Generic Doryx Antibiotic Ban

December 15, 2011

(Updates with Warner Chilcott comment in sixth paragraph.)

Dec. 12 (Bloomberg) -- Mylan Inc. won an appeals court ruling in its bid to sell generic versions of Warner Chilcott Plc’s antibiotic Doryx.

The U.S. Court of Appeals for the Federal Circuit in Washington said a judge erred when granting an order that bans Mylan from selling the copy while a patent-infringement lawsuit is pending. The judge should have listened to some of the expert testimony in the case before ruling, the appeals court said as it remanded the case for further proceedings.

Doryx generated sales of $127 million in the first nine months of the year, Dublin-based Warner Chilcott said Nov. 4, or about 6 percent of the company’s total revenue. Warner Chilcott contends that Mylan shouldn’t be allowed to sell low-cost versions of the medicine until a patent on a modified coating for the drug expires in December 2022.

Mylan contends the patent is invalid, and the Federal Circuit said the Canonsburg, Pennsylvania, company’s arguments weren’t addressed when District Judge William Martini in Newark, New Jersey, ruled that Warner Chilcott was likely to win the case.

A trial in the underlying patent dispute may be held next month, and the Federal Circuit said the judge could consider issuing a temporary order banning Mylan’s copy until that time.

Warner Chilcott said in a statement it will ask the appeals court to reconsider its decision, and, if needed, will seek an order from the district court to prevent Mylan from selling the generic drug should it receive final approval from the U.S. Food and Drug Administration.

The case is Warner Chilcott Laboratories Ireland Ltd. v. Mylan Pharmaceuticals Inc., 2011-1611, U.S. Court of Appeals for the Federal Circuit (Washington). The lower court case is Warner Chilcott Laboratories v. Mylan Pharmaceuticals Inc., 09-cv-2073, U.S. District Court, District of New Jersey (Newark).

--With assistance from David Voreacos in Newark, New Jersey. Editors: Romaine Bostick, Michael Shepard

To contact the reporters on this story: Susan Decker in Washington at sdecker1@bloomberg.net;

To contact the editor responsible for this story: Michael Shepard at mshepard7@bloomberg.net


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